Senior Quality Engineer, Medical Devices & Design Controls

Heartstream; Bothell (WA); On-site; USD 100,000 - 145,000; Full time

Benefits offered by this job

PTO

401k match

HSA

Stock purchase plan

Education reimbursement

Total Rewards benefits

Job summary

Heartstream is seeking an experienced Quality Engineer to lead design quality activities across the product lifecycle, ensuring new products transition smoothly into production while meeting regulatory requirements. You will collaborate with R&D, Manufacturing, Regulatory Affairs and Product Quality teams to drive reliability and quality improvements in global markets.

Ideal candidates have 8–10+ years in related roles (or 5+ with a Master’s), strong knowledge of design controls, risk

Qualifications

• 8–10+ years of experience in Quality Engineering, Design Quality, Product Quality, Safety Engineering, R&D Engineering, or related discipline (or 5+ years with a Master's).
• Design Controls, Process Validation, Design Verification & Validation, Risk Management, CAPA, Root Cause Analysis, Reliability Engineering, Design for Quality (DFQ), Statistical Analysis, and Regulatory Compliance experience.
• Bachelor's or Master's Degree in Mechanical Engineering, Electronics Engineering, Science, or related technical discipline; Six Sigma Green Belt preferred.
• Ability to meet minimum Physical, Cognitive, and Environmental job requirements, with or without reasonable accommodation.
• Collaborative and influential professional with excellent communication and stakeholder management skills; comfortable mentoring others and driving continuous improvement; travel as needed.

Responsibilities

• Lead design quality activities across the product lifecycle, ensuring new products are transitioned into production while meeting quality and regulatory requirements.
• Partner with R&D, Manufacturing, Regulatory Affairs, and Product Quality teams to drive product reliability, quality improvements, and global regulatory compliance.
• Influence the development of innovative life-saving medical technologies by guiding design controls, validation strategies, risk management, and post-market quality activities.
• Utilize post-market surveillance insights and field performance data to continually improve product quality, safety, and reliability.
• Build strong relationships across cross-functional teams, providing quality leadership, guidance, and mentorship to support product launches and sustained excellence.
• Develop deep expertise in systems-level quality engineering, design controls, process validation, risk management, and regulatory compliance within the medical device industry.

Skills

Design Quality

Quality Engineering

Risk Management

Regulatory Compliance

CAPA

Design Controls

Root Cause Analysis

Post Market Surveillance

Education

Bachelor's or Master's in Mechanical/Electronics Engineering or related field

Six Sigma Green Belt (preferred)

Job description

Heartstream is seeking an experienced Quality Engineer to lead design quality activities across the product lifecycle, ensuring new products transition smoothly into production while meeting regulatory requirements. You will collaborate with R&D, Manufacturing, Regulatory Affairs and Product Quality teams to drive reliability and quality improvements in global markets.

Ideal candidates have 8–10+ years in related roles (or 5+ with a Master’s), strong knowledge of design controls, risk